The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale
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The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD) : essential study design and rationale. / Bressendorff, Iain; Hansen, Ditte; Schou, Morten; Kragelund, Charlotte; Brandi, Lisbet.
I: B M J Open, Bind 7, Nr. 6, e016795, 06.2017.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD)
T2 - essential study design and rationale
AU - Bressendorff, Iain
AU - Hansen, Ditte
AU - Schou, Morten
AU - Kragelund, Charlotte
AU - Brandi, Lisbet
N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
PY - 2017/6
Y1 - 2017/6
N2 - INTRODUCTION: Chronic kidney disease (CKD) is associated with an increased risk of cardiovascular disease and mortality, which is thought to be caused by increased propensity towards vascular calcification (VC). Magnesium (Mg) inhibits phosphate-induced VC in vitro and in animal models and serum Mg is inversely associated with cardiovascular mortality in predialysis CKD and in end-stage renal disease. This paper will describe the design and rationale of a randomised double-blinded placebo-controlled multicentre clinical trial, which will investigate whether oral Mg supplementation can prevent the progression of coronary artery calcification (CAC) in subjects with predialysis CKD.METHODS AND ANALYSIS: We will randomise 250 subjects with estimated glomerular filtration rate of 15 to 45 mL/min/1.73 m2 to 12 months treatment with either slow-release Mg hydroxide 30 mmol/day or matching placebo in a 1:1 ratio. The primary end point is change in CAC score as measured by CT at baseline and after 12 months treatment. Secondary end points include change in pulse wave velocity, bone mineral density, measures of mineral metabolism and clinical end points related to cardiovascular and renal events.ETHICS AND DISSEMINATION: This trial has been approved by the local biomedical research ethics committees and data protection agencies and will be performed in accordance with the latest revision of the Helsinki Declaration. The trial will examine for the first time the effect of increasing the uptake of a putative VC inhibitor (ie, Mg) on progression of CAC in subjects with predialysis CKD.TRIAL REGISTRATION NUMBER: NCT02542319, pre-results.
AB - INTRODUCTION: Chronic kidney disease (CKD) is associated with an increased risk of cardiovascular disease and mortality, which is thought to be caused by increased propensity towards vascular calcification (VC). Magnesium (Mg) inhibits phosphate-induced VC in vitro and in animal models and serum Mg is inversely associated with cardiovascular mortality in predialysis CKD and in end-stage renal disease. This paper will describe the design and rationale of a randomised double-blinded placebo-controlled multicentre clinical trial, which will investigate whether oral Mg supplementation can prevent the progression of coronary artery calcification (CAC) in subjects with predialysis CKD.METHODS AND ANALYSIS: We will randomise 250 subjects with estimated glomerular filtration rate of 15 to 45 mL/min/1.73 m2 to 12 months treatment with either slow-release Mg hydroxide 30 mmol/day or matching placebo in a 1:1 ratio. The primary end point is change in CAC score as measured by CT at baseline and after 12 months treatment. Secondary end points include change in pulse wave velocity, bone mineral density, measures of mineral metabolism and clinical end points related to cardiovascular and renal events.ETHICS AND DISSEMINATION: This trial has been approved by the local biomedical research ethics committees and data protection agencies and will be performed in accordance with the latest revision of the Helsinki Declaration. The trial will examine for the first time the effect of increasing the uptake of a putative VC inhibitor (ie, Mg) on progression of CAC in subjects with predialysis CKD.TRIAL REGISTRATION NUMBER: NCT02542319, pre-results.
KW - Adolescent
KW - Adult
KW - Aged
KW - Bone Density
KW - Coronary Artery Disease/diagnostic imaging
KW - Denmark
KW - Disease Progression
KW - Double-Blind Method
KW - Female
KW - Glomerular Filtration Rate
KW - Humans
KW - Kidney Failure, Chronic/complications
KW - Linear Models
KW - Logistic Models
KW - Magnesium/administration & dosage
KW - Male
KW - Middle Aged
KW - Norway
KW - Pulse Wave Analysis
KW - Renal Insufficiency, Chronic/complications
KW - Research Design
KW - Tomography, X-Ray Computed
KW - Vascular Calcification/diagnostic imaging
KW - Young Adult
U2 - 10.1136/bmjopen-2017-016795
DO - 10.1136/bmjopen-2017-016795
M3 - Journal article
C2 - 28645983
VL - 7
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 6
M1 - e016795
ER -
ID: 196041180